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The Food and Drug Administration (FDA) today awarded Dr. W. Leigh Thompson the Commissioner's Special Citation for Multiple Innovative Contributions to Public Health and Wellbeing.
In a career spanning nearly four decades, Dr. Thompson has made significant contributions to medical care, drug development, and the public health. He has pursued collaborative drug development innovations with FDA colleagues, and developed clinical trial reference ranges adopted for broad use by the agency. He consulted with FDA on topics of drug and device development, global regulatory strategies, health informatics, strategic planning, research management, and process re-engineering.
At the Medical University of South Carolina Dr. Thompson earned a Masters Degree in Science and a Ph.D. (1962). His doctoral dissertation in pharmacology involved the discovery and development of hetastarch (Hespan), which became a widely used substitute for blood. Dr. Thompson earned a medical degree at The Johns Hopkins University in 1965 where he performed clinical trials and completed the New Drug Application (NDA) for hetastarch.
After completing a residency at the Johns Hopkins Osler Medical Service, Dr. Thompson then spent two years at the National Institutes of Health working at the National Cancer Institute (NCI) where he developed NCI's first critical care unit and its first electronic records of patient therapy.
From 1970 to 1974 as an Assistant Professor of Medicine and of Pharmacology and Experimental Therapeutics at Johns Hopkins he developed and led the Medical Critical Care Unit, directed the Medical Emergency Department, pioneered computer-assisted instruction in pharmacokinetics and computer-based patient outcomes studies, and started the advanced practice nurse (Emergency Department Practitioner) program. He performed two-thirds of the NDA clinical trials of dopamine and was a scientific pioneer in the field of medical monitoring devices.
From 1974 to 1982 as Professor of Medicine at Case Western Reserve University, he founded and led programs in clinical pharmacology and critical care medicine (building his third ICU), directed the medical emergency department, founded and directed weekly live telecasts and videotape for continuing medical education (Medicine Today), and developed the Northeast Ohio Poison Treatment Center, Cleveland Drug Analysis Laboratory, and University Hospitals Drug Information Center. Dr. Thompson was a medical news reporter for NBC-TV where his taped and live reports contributed to a prize-winning series.
Dr. Thompson developed novel treatments of poisoning: inventing a potent oral charcoal and a safe inhalation emetic (drug product to induce vomiting in poisoning cases). He also held grants for organizing and studying poisoning care in Northeast Ohio, for training in critical care and clinical pharmacology, and performed numerous Phase I through III clinical trials.
In 1982 he joined Eli Lilly and Company as Director of Clinical Investigation of Lilly Research Laboratories and was eventually promoted to Executive Vice President of Lilly Research Laboratories during which time he pioneered remote data entry, direct capture of data from patients, use of a single global pivotal study in 24 countries, the first rDNA product (Humulin), the first modified rDNA product (Humalog), the first global electronic safety network including automated regulatory reporting, and one of the fastest NDA approvals (hGH) prior to 1990.
In 1993 he was promoted to Chief Scientific Officer of Eli Lilly and Company. In 1994 he was awarded a Doctor of Medical Sciences honorary degree by the Medical University of South Carolina and was their 1999 Distinguished Alumnus. In 2003 he was elected to membership in The Johns Hopkins Society of Scholars and the 2003 Distinguished Medical Alumnus. He is an Honorary Life Member and past President of the Society of Critical Care Medicine and is the founder and original Co-Editor of The Textbook of Critical Care, and Critical Care: State of the Art. He has authored 300 scientific papers, edited ten books, and writes many monographs for about 50 major lectures a year worldwide (and is broadly acknowledged as one of the best public speakers in medicine).
After his retirement from Lilly in 1995, Thompson was CEO of Profound Quality Resources, Ltd., where he consulted worldwide with academic health centers and with manufacturers of drugs, devices, and diagnostics. He was an initial member of the Council for International Organizations of Medical Science (CIOMS) program in global adverse event reporting and in International Conference on Harmonization (ICH) of regulatory requirements. In 1993 he was promoted to Chief Scientific Officer of Eli Lilly and Company.
His pioneering initiatives in critical care, pharmaceutical development innovations, information technology management and collaborations with regulators has been remarkable and left a sustaining positive impact on the industry, patients and the many professionals whom he has mentored.
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